Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)

Официальное название

Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy

Обзор

This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled. The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not. Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.

Подробное описание

The study ATHENEA is a phase II clinical trial intending to enroll 97 patients, who will receive Atezolizumab + Paclitaxel + Carboplatin as induction/neoadjuvant treatment. After the induction treatment all patients will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.

Depending on the decision each patient will be treated in a different way.

The study is an open-label, phase II, multicenter clinical trial for previously untreated adult patients with stage to IIIA and IIIB non-small cell lung cancer.

The primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population.

Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death.

The total trial duration will be 10 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded.

Вмешательства

• Препарат Atezolizumab
  Patients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
• Препарат Paclitaxel
  Neoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Paclitaxel: Intravenous infusion. Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
• Препарат Carboplatin
  Neoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin\* \*Infusion according to the standard of each center Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: From the date of randomization until end of follow up, up to 60 months.]

Вторичные конечные точки (3)

• Resectability rate (%) [Срок оценки: From the date of randomization until end of follow up, up to 60 months.]
• Pathological complete response (pCR) [Срок оценки: From the date of randomization until end of surgery, up to 6 months]
• Overall survival (OS) [Срок оценки: From the date of randomization until end of follow up, up to 60 months.]

Критерии участия

Критерии включения

• Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)
• Confirm the absence of distant disease
• ECOG (Performance status) 0-1
• Adequate hematologic and organ function
• All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
• Adequate lung function
• Patients aged > 18 years
• For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
• For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception
• Oral contraception should always be combined with an additional contraceptive method
• Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
• Patient capable of proper therapeutic compliance and accessible for correct follow-up

Критерии исключения

• Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.
• Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
• Weight loss >10% within the previous 3 months.
• Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.
• Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment
• Pleural or pericardial effusion
• Known hypersensitivity or allergy to atezolizumab formulation.
• History of autoimmune disease or lung disease
• Positive test for human immunodeficiency viruses (HIV)
• Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus.
• Active tuberculosis.
• Symptomatic neuropathy grade > 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
• Severe infections within 4 weeks prior to be included in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 21 центр

• Hospital General Universitario Dr. Balmis de Alicante — Alicante
• ICO Badalona, Hospital Germans Trias i Pujol — Badalona
• Hospital Universitari Vall d' Hebron — Barcelona
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Parc Taulí — Barcelona
• Hospital De Basurto — Bilbao
• Hospital Univ. De Jerez De La Frontera — Jerez de la Frontera
• ICO Girona, Hospital Josep Trueta — Girona
• … и ещё 13 центров

Идентификаторы

NCT: NCT07153445 · GECP 23/02_ATHENEA · 2024-515984-68-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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